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Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer

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ClinicalTrials.gov Identifier: NCT00055692
Recruitment Status : Completed
First Posted : March 7, 2003
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Primary Hepatocellular Carcinoma
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Intervention Biological: bevacizumab
Enrollment 46
Recruitment Details A total of 46 patients were enrolled between February 2003 and September 2006
Pre-assignment Details  
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Baseline Participants 46
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[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
58
(21 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
8
  17.4%
Male
38
  82.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
White 25
Black 2
Hispanic 5
Asian 14
1.Primary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame At 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65
(51 to 79)
2.Primary Outcome
Title Disease Response
Hide Description MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame MRI is required at weeks 8, 16 and then every 12 weeks until disease progression
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
6
(3 to 23)
3.Primary Outcome
Title Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.
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Time Frame Baseline and 8 weeks after bevacizumab therapy
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Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.
Arm/Group Title Treatment (Bevacizumab): Baseline Treatment (Bevacizumab): 8 Weeks
Hide Arm/Group Description:

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: relative MR units
37.3  (18.4) 18.4  (12.4)
4.Primary Outcome
Title Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition
Hide Description [Not Specified]
Time Frame During treatment
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Hide Analysis Population Description
Six of eight patients were analyzed after 8 weeks of bevacizumab therapy
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
249  (175)
5.Primary Outcome
Title To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition
Hide Description [Not Specified]
Time Frame During and after treatment
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No data was collected by the principal investigator for this outcome
Arm/Group Title Treatment (Bevacizumab)
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Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Disease Stability
Hide Description [Not Specified]
Time Frame At 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Bevacizumab)
Hide Arm/Group Description

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given orally

All-Cause Mortality
Treatment (Bevacizumab)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Bevacizumab)
Affected / at Risk (%) # Events
Total   22/46 (47.83%)    
Gastrointestinal disorders   
Hemorrhage  5/46 (10.87%)  5
Ascites  2/46 (4.35%)  2
Anorexia  1/46 (2.17%)  1
Investigations   
Increased AST  1/46 (2.17%)  1
Increased ALT  1/46 (2.17%)  1
Increased alkaline phosphatase  1/46 (2.17%)  1
Increased bilirubin  5/46 (10.87%)  5
Renal and urinary disorders   
Proteinuria  2/46 (4.35%)  2
Vascular disorders   
Hypertension  7/46 (15.22%)  7
Arterial thrombosis  2/46 (4.35%)  2
Venous thrombosis  1/46 (2.17%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Bevacizumab)
Affected / at Risk (%) # Events
Total   41/46 (89.13%)    
Gastrointestinal disorders   
Hemorrhage  7/46 (15.22%)  7
Ascites  3/46 (6.52%)  3
vomiting  5/46 (10.87%)  5
Anorexia  4/46 (8.70%)  4
Nausea  5/46 (10.87%)  5
General disorders   
Fatigue  15/46 (32.61%)  15
Investigations   
Thrombocytopenia  6/46 (13.04%)  6
Increased AST  9/46 (19.57%)  9
Increased ALT  8/46 (17.39%)  8
Increased alkaline phosphatase  4/46 (8.70%)  4
Increased bilirubin  7/46 (15.22%)  7
Renal and urinary disorders   
Proteinuria  17/46 (36.96%)  17
Respiratory, thoracic and mediastinal disorders   
Epistaxis  5/46 (10.87%)  5
Skin and subcutaneous tissue disorders   
Rash  6/46 (13.04%)  6
Vascular disorders   
Hypertension  8/46 (17.39%)  8
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa Escobar-Peralta, Program Manager
Organization: Montefiore Medical Center
Phone: 718-379-6866
EMail: lescobar@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055692     History of Changes
Other Study ID Numbers: NCI-2012-02518
NCI-2012-02518 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-5611 ( Other Identifier: NCI/CTEP )
5611 ( Other Identifier: CTEP )
P30CA013330 ( U.S. NIH Grant/Contract )
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: March 6, 2003
First Posted: March 7, 2003
Results First Submitted: August 25, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016